To Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to Healthy Children of 4-6 Years

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04618640
• Date of registration: 01/11/2020
• Prospective Registration: No
• Primary sponsor: Boryung Biopharma Co., Ltd.
• Public title: To Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to Healthy Children of 4-6 Years Aladdin
• Scientific title: A Multicenter, Single-group, Phase III Study to Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to Healthy Children of 4-6 Years Who Completed the Primary Vaccination Against Diphtheria, Tetanus, Pertussis, and Poliomyelitis by Participating in the Phase III Study, BR-DTPP-CT-301, or by Receiving Routine Vaccination
• Date of first enrolment: December 26, 2019
• Target sample size: 249
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04618640
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Korea, Republic of

Contacts

• Name: Sunhye IM

• Name: Byeonguk Eun
• Affiliation: Eulji University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

1. A subject's parent/legal representative provides a written consent after being
informed about the study objective, methods, effect of the study vaccine, and other
relevant information

2. Documented record of the three doses of primary immunization against diphtheria,
tetanus, pertussis, and polio either by participating in the previous study,
BR-DTPP-CT-301 or by following the national immunization schedule under usual clinical
setting (the primary immunization should have been initiated after 6 weeks of age and
at minimal interval of 4 weeks)

3. Receipt of a boosting dose against diphtheria, tetanus, and pertussis until 2 years of
age; therefore, total of four vaccination records against diphtheria, tetanus, and
pertussis and three against polio

4. Healthy male or female children, aged 4 to 6 years on the day of the vaccination

Exclusion Criteria:

1. Children aged 7 years or older

2. Previously received DTaP vaccine five times or more, including the doses received in
the BR-DTPP-CT-301 study, either by a combination vaccine or a separate vaccine

3. Previously received IPV vaccine four times or more, including the doses received in
the BR-DTPP-CT-301 study, either by a combination vaccine or a separate vaccine

4. The fourth dose of DTaP vaccine was postponed and administered after 4 years of age

5. Acute febrile illness with fever = 38.0°C (tympanic) on the day of the vaccination

6. Moderate to severe systemic acute illness with or without fever

7. History of diphtheria, tetanus, pertussis, or polio (poliomyelitis)

8. Dysfunctional immune system or congenital or acquired immunodeficiency

9. Had encephalopathy of unknown etiology within 7 days following a previous dose of DTaP
vaccine

10. Received a vaccine other than the protocol-permitted vaccines within 28 days from the
study vaccination day or are planned to receive such a vaccine during the study period

11. Received systemic corticosteroid treatment at immunosuppressive dosage within 28 days
from the study vaccination day or are planned to receive such a treatment during the
study period (exceptionally, administration of prednisolone = 0.5 mg/kg/day for up to
14 continuous days is allowed)

12. Received immunoglobulins or blood products within 90 days before the study vaccination
day or are planned to receive such products during the study period

13. Had severe allergic reaction (e.g. anaphylaxis) to ingredients of the investigational
product or bears such a possibility

14. Currently enrolled in another clinical trial or planned to participate in another
clinical trial

15. Any other reasons that preclude the eligibility of the subject, based on
investigator's decision



Age minimum: 4 Years
Age maximum: 6 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diphtheria

Pertussis

Poliomyelitis

Tetanus

Intervention(s)

Biological: DTaP-IPV combination vaccine

Primary Outcome(s)

Seroconversion rate after boosting vaccination [Time Frame: boosting vaccination after Day 28 [+14 days]]

Secondary Outcome(s)

Geometric mean ratio (GMR) between the pre- and post-booster antibody level [Time Frame: Day 1 Pre-vaccination and boosting vaccination after Day 28 [+14 days]]

GMR between the pre- and post-booster antibody level in each subgroup depending on the pre-booster antibody level (= seroprotective/seropositive level or < seroprotective/seropositive level) [Time Frame: Day 1 Pre-vaccination and boosting vaccination after Day 28 [+14 days]]

Minimal seroprotection rate for anti-DT and anti-TT (= 0.01 IU/mL) before boosting vaccination [Time Frame: Day 1 Pre-vaccination]

Post-booster antibody level [Time Frame: boosting vaccination after Day 28 [+14 days]]

Pre-booster antibody level [Time Frame: Day 1 Pre-vaccination]

Proportion of subjects with post-booster antibody levels for anti-DT and anti-TT =1.0 IU/mL [Time Frame: boosting vaccination after Day 28 [+14 days]]

Reverse cumulative distribution curves for pre- and post-booster antibody level [Time Frame: Day 1 Pre-vaccination and boosting vaccination after Day 28 [+14 days]]

Seroprotection rate for anti-DT, anti-TT, and anti-poliovirus or seropositive (>30 IU/mL) rate for anti-PT and anti-FHA after boosting vaccination [Time Frame: boosting vaccination after Day 28 [+14 days]]

Seroprotection rate for anti-DT, anti-TT, and anti-poliovirus or seropositive (>30 IU/mL) rate for anti-PT and anti-FHA before boosting vaccination [Time Frame: Day 1 Pre-vaccination]

Secondary ID(s)

BR-DTPP-CT-302

Source(s) of Monetary Support

Please refer to primary and secondary sponsors